Ileostomy Infusion for Ileostomy

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of California, San Diego

Disqualifiers: Unable to consent, stoma infusion

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Ileostomy Infusion for Ileostomy?

The research suggests that similar treatments, like the reinfusion of succus entericus (intestinal fluid), can improve short-term outcomes by reducing hospital stays and improving bowel function after ileostomy closure. Additionally, injecting liquid nutrients into the pelvic pouch before ileostomy closure has been shown to reduce stool frequency and improve continence. ^{1 2 3 4 5}

What is the purpose of this trial?

This research study is being conducted to study the effect of infusing your contents from your ostomy bag back into your intestine to re-train them prior to the ostomy takedown operation, which is a surgery to reverse your ostomy to put your intestine back together. Because your intestine past the ostomy hasn't seen any intestinal content for several weeks to months before the takedown operation, it is no longer used to handling the daily work of processing intestinal content and will take time to recover its normal function after surgery. We hope to speed up this process by training them before your planned surgery.

Eligibility Criteria

This trial is for individuals with a temporary loop ileostomy who are preparing for an operation to reverse the ostomy. Participants must be able to infuse contents from their ostomy bag back into their intestine and give consent.

Inclusion Criteria

I have a temporary loop ileostomy and am being evaluated for its removal.

Exclusion Criteria

I cannot perform stoma infusion by myself.

I am unable to give consent by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Intestinal Training

Participants undergo infusion of contents from the ostomy bag back into the intestine to re-train them prior to the ostomy takedown operation

2 weeks

Regular visits for infusion training

Surgery and Immediate Recovery

Participants undergo the ostomy takedown operation and are monitored for the return of bowel function

1-5 days

Inpatient stay for surgery and recovery

Follow-up

Participants are monitored for complications and ease of stoma infusion post-surgery

30 days

Follow-up visits to assess recovery and complications

Treatment Details

Interventions

• Ileostomy Infusion

Trial Overview The study tests whether infusing intestinal contents from an ostomy bag back into the intestine before surgery can re-train the bowel and help it recover normal function faster after the reversal operation.

Participant Groups

Group I: Ileostomy infusion Active Control 1 Intervention

perform infusion if ileostomy prior to takedown operation

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Temporary end ileostomy with subcutaneously buried efferent limb: results and potential advantages. [2010]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of the Ileostomy Pathway in Reducing Readmissions for Dehydration: Does It Stand the Test of Time? [2021]

3. England pubmed.ncbi.nlm.nih.gov

Self-administered succus entericus reinfusion before ileostomy closure improves short-term outcomes. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Attempts to aid the adaptation of pelvic pouch before temporary ileostomy closure. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Excessive weight gain is associated with an increased risk for pouch failure in patients with restorative proctocolectomy. [2022]